Quality Engineer
Autocam Medical
Date: 8 hours ago
City: Murfreesboro, TN
Contract type: Full time
Brief Description
The Quality Engineer is responsible for understanding customer quality related requirements, driving internal efforts for root cause and quality improvement, while supporting our high standards of precision and quality products in the inspection of medical parts.
Duties And Responsibilities
The Quality Engineer is responsible for understanding customer quality related requirements, driving internal efforts for root cause and quality improvement, while supporting our high standards of precision and quality products in the inspection of medical parts.
Duties And Responsibilities
- Establish and participate in supplier qualification/development activities.
- Lead/Develop/Use Key Process Indicators to determine process effectiveness, identify areas for improvement, best practices, and drive continuous quality improvement.
- Lead/Drive corrective, preventive, and closure actions for project issues related to quality and/or test non-conformance.
- Work closely with production line and ensure all necessary controls are enforced to be compliant with ISO 13485 and FDA QSR requirements.
- May ensure that quality reporting (e.g. incoming and in-process quality trends; returns analysis, categorization and corrective action activity, etc.) is maintained and documented with the assigned team.
- Perform analysis of reports and production data to identify trends and recommend updates to changes to the Quality System Regulations, Standards, and/or guideline procedures when necessary.
- Determines quality improvement parameters by identifying statistical methods relevant to manufacturing processes.
- Establishes statistical confidence by identifying sample size and acceptable error; determining levels of confidence.
- Develops sampling plans by applying attribute, variable, and sequential sampling methods.
- Maintains statistical process controls by applying demerit/unit, zone charting, and x2 charts for distributions and individual-medial/range for multi-stream processes.
- Analyzes data by completing hypothesis, normal distribution, and process capability analysis tests.
- Prepares reports by collecting, analyzing, and summarizing data; making recommendations.
- Contributes to team effort by accomplishing related results as needed.
- Strong interpersonal and presentation skills needed to interact with external customers as well as with all levels within the company.
- Must demonstrate excellent writing skills with ability to prepare/review and/or approve technical documentation.
- Thorough knowledge and experience surrounding quality control inspection.
- Previous Medical Device experience in a quality role is preferred but not required.
- Knowledge of ISO 9001, ISO 13485 standards and/or FDA 21 CFR part 820 a plus.
- Minimum Bachelor’s degree in an Engineering or Science discipline
- Green Belt or ASQ certification a plus.
- Proven problem-solving experience
- Ability to work in an entrepreneurial, fast pace and rapidly evolving environment
How to apply
To apply for this job you need to authorize on our website. If you don't have an account yet, please register.
Post a resumeSimilar jobs
Insurance Preauthorization Specialist
National HealthCare Corporation (NHC),
Murfreesboro, TN
5 days ago
Job DetailsDescriptionInsurance Preauthorization Clerk for our Murfreesboro, TN location NHC HomeCare TN Regional is looking for an Insurance Preauthorization Specialist to join our team. Responsible for verifying and obtaining authorizations from insurance companies under the plan coverage for all appropriate patients. Communicates with patients regarding updated insurance information where applicable and coordinates the information with clinicians.QualificationsHigh School Diploma.One year business/healthcare...
Administrative Assistant
RHA Health Services, LLC,
Murfreesboro, TN
3 weeks ago
We are hiring for:Administrative AssistantType:RegularIf you are a positive and personable individual looking for a satisfying and fun opportunity to make a real difference in the lives of people with intellectual, developmental disabilities, and people facing mental health, and substance use challenges, join our team at RHA Health Services!Administrative Assistant assists the Regional Administrator in setup and maintenance of medical...
Dental Assistant
Aspen Dental,
Murfreesboro, TN
4 weeks ago
At Aspen Dental, we put You First, offering the security and job stability that comes with working with a world-class dental service organization (DSO). Our best-in-class training program, competitive compensation, and flexible scheduling will help you thrive in your career. When you join our team as a Dental Assistant, you will have the opportunity to give back to communities and...
